On May 10, 2021 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported financial results for the first quarter ending March 31, 2021 and provided a corporate update (Press release, VBI Vaccines, MAY 10, 2021, View Source [SID1234579598]).

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Jeff Baxter, VBI’s President and CEO commented: "The first quarter of 2021 marked the beginning of a transformational year for VBI with notable developments across our lead pipeline programs targeting hepatitis B (HBV), coronaviruses, including different variants of COVID-19, and glioblastoma (GBM). We continue to support the U.S. and European regulatory bodies in their review of our 3-antigen HBV vaccine candidate, and we look forward to ongoing discussions throughout the year. Additionally, our partnerships have enabled us to aggressively advance our pipeline candidates, including the initiation of a first-in-class Phase 2 combination study assessing a potential functional cure regimen for chronic HBV infection as well as a suite of coronavirus vaccine candidates. Most recently, the partnership we entered into with CEPI supports the development of VBI’s enveloped virus-like particle (eVLP) vaccine candidates against known and emerging variants of COVID-19, including B.1.351, the variant first identified in South Africa. With the strength of these partnerships and our financial position, we believe we are well positioned to meet the numerous regulatory and clinical milestones expected over the coming months."

Q1 2021 Key Program Achievements and Anticipated Upcoming Milestones

Hepatitis B (HBV)

3-Antigen HBV Prophylactic Vaccine Candidate

November 30, 2021: U.S. Prescription Drug User Fee Act (PDUFA) target action date set by U.S. Food and Drug Administration (FDA)
European Medicines Agency (EMA) regulatory review ongoing, following acceptance of Marketing Authorization Application (MAA) filing in December 2020
Submissions to United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) and to Health Canada are in process and are expected to be completed this year
VBI-2601 (BRII-179) : HBV Immunotherapeutic

April 2021: Additional data from Phase 1b/2a study in chronic HBV patients demonstrated robust HBV-specific T cell and antibody responses across all study arms
April 2021: Phase 2 combination study of VBI-2601 (BRII-179) and BRII-835 (VIR-2218), Vir Biotechnology’s investigational HBV-targeting siRNA, initiated by partner and trial sponsor, Brii Biosciences (Brii Bio)
2021: Complete Phase 1b/2a study dataset targeted for presentation at scientific conference later this year
COVID-19 & Coronaviruses

March 2021: Announcement of partnership with Coalition for Epidemic Preparedness Innovations (CEPI) – CEPI to provide up to $33 million of funding to support development of VBI’s enveloped virus-like particle (eVLP) vaccine candidates against COVID-19 variants of concern
VBI-2902 : Monovalent COVID-19 Vaccine Candidate

Vaccine candidate supported by funding from the Strategic Innovation Fund of the Government of Canada
March 2021: Adaptive Phase 1/2 clinical study initiated in adults in Canada
Q2 2021: Initial data from ongoing Phase 1/2 study expected by the end of the second quarter
VBI-2905 : Monovalent COVID-19 (B.1.351 Variant) Vaccine Candidate

Vaccine candidate supported by funding from CEPI
Mid-year 2021: Phase 1 clinical study expected to initiate
VBI-2901 : Multivalent Pan-Coronavirus Vaccine Candidate

Vaccine candidate supported by funding from the Strategic Innovation Fund of the Government of Canada
H2 2021: Phase 1 clinical study expected to initiate
Glioblastoma (GBM)

VBI-1901: Cancer Vaccine Immunotherapeutic Candidate

Q2 2021: Additional data, including tumor response and 6-month and 12-month overall survival data from Phase 2a (Part B) of ongoing Phase 1/2a study expected
Q4 2021: Expected initiation of a randomized, controlled clinical study with the potential to yield registrational data
Financing

Throughout the first quarter of 2021, VBI raised total gross proceeds of $22.1 million, issuing 5.8 million shares at an average price of $3.84 through its Open Market Sales AgreementSM, established July 31, 2020 with Jefferies LLC
First Quarter 2021 Financial Results

Cash Position: VBI ended the first quarter of 2021 with $133.6 million in cash, cash equivalents, and short-term investments compared with $119.1 million as of December 31, 2020.
Net Cash Used in Operating Activities: Net cash used in operating activities for the three months ended March 31, 2021 was $6.6 million, compared to $7.6 million for the same period in 2020. The decrease is largely a result of the change in operating working capital, notably the cash received in advance from the CEPI funding agreement, offset by an increase in net loss.
Cash Used for Purchase of Property and Equipment: Cash used for the purchase of property and equipment was $0.6 million for the three months ended March 31, 2021, compared to $0.1 million for the same period in 2020. The increase is a result of routine purchases of property and equipment.
Revenue: Revenue in the first quarter of 2021 was $0.3 million, compared to $0.4 million for the same period in 2020. The decrease in revenues was due to a decrease in R&D services revenue as part of the collaboration with Brii Bio. Fewer manufacturing and non-clinical research services were required in the three months ended March 31, 2021 compared to the three months ended March 31, 2020.
Cost of Revenues: Cost of revenues was $2.4 million in the first quarter of 2021 as compared to $2.6 million for the same period in 2020. The decrease in the cost of revenues was due to the decrease in VBI-2601 R&D services referenced above.
Research and Development (R&D): R&D expenses for the first quarter of 2021 were $6.8 million compared to $3.2 million in the first quarter of 2020. The increase was a result of increased expenses related to our coronavirus vaccine program, which was offset by a decrease in the R&D expenses related to the 3-antigen prophylactic HBV vaccine candidate, the final Phase 3 clinical study of which (CONSTANT) completed in January 2020, and regulatory costs related to the BLA submission for the 3-antigen prophylactic HBV vaccine candidate.
General and Administrative (G&A): G&A expenses were $6.7 million for the first quarter of 2021, compared to $4.1 million for the same period in 2020. The increase was a result of the increased pre-commercialization activities related to the 3-antigen prophylactic HBV vaccine candidate in preparation for potential regulatory approvals, in addition to increased insurance and labor costs.
Net Loss: Net Loss and net loss per share for the first quarter of 2021 were $17.6 million and $0.07, respectively, compared to a net loss of $8.4 million and a net loss per share of $0.05 for the first quarter of 2020.

On May 10, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that data from pre-clinical studies of its RAF inhibitor candidate, KIN-2787, have been selected for a poster presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Kinnate Biopharma, MAY 10, 2021, View Source [SID1234579597]). The ASCO (Free ASCO Whitepaper) meeting will be held virtually from June 4-8, 2021.

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"As we advance towards the initiation of clinical studies for our lead RAF inhibitor program, we are honored to be selected by the ASCO (Free ASCO Whitepaper) Scientific Program Committee to present findings from our pre-clinical studies of KIN-2787 at this year’s Annual Meeting," said Eric Murphy, Ph.D., co-founder and Chief Scientific Officer of Kinnate. "We are enthusiastic about the advancement of KIN-2787 to address actionable RAF mutations in molecular subtypes that are not addressed by existing drugs or are resistant to available standard-of-care therapies."

Oncogenic BRAF gene alterations, leading to aberrantly activated BRAF monomers (Class I mutations) or dimers (Class II and Class III mutations), are observed in approximately 6% of all human cancers. First-generation BRAF inhibitors targeting Class I BRAF mutants, including dabrafenib, encorafenib, and vemurafenib, provide significant clinical benefit to patients with BRAF V600 mutation-driven melanoma and select solid tumors as monotherapies or in combination with other targeted therapies. The currently approved BRAF inhibitors have not, however, proven to be effective in patients with Class II or III BRAF alterations. For example, approximately 62% of BRAF mutations in non-small-cell lung carcinoma (NSCLC) and approximately 21% of BRAF mutations in melanoma are identified as Class II and Class III BRAF mutations where the currently approved Class I inhibitors are not effective.

The data to be presented at the ASCO (Free ASCO Whitepaper) annual meeting were derived from pre-clinical studies evaluating the efficacy and tolerability of KIN-2787 in vitro and in vivo in BRAF mutation-driven human cancer models. A phase 1 dose escalation and expansion clinical trial evaluating the safety and efficacy of KIN-2787 monotherapy in patients with advanced or metastatic solid tumors harboring BRAF gene alterations, including Class II and III mutations, is expected to initiate in 2021.

Additional information on the ASCO (Free ASCO Whitepaper) annual meeting can be found online at: View Source Per ASCO (Free ASCO Whitepaper)’s Embargo & Release Information, complete abstracts will be released to the public on ASCO (Free ASCO Whitepaper)’s Meeting Library, View Source, at 5:00 p.m. ET on May 19, 2021.

Kinnate’s poster presentation will become available for on-demand viewing beginning Friday, June 4, 2021 at 9:00 a.m. ET, and can be accessed at: View Source

On May 10, 2021 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that it will host a first quarter 2021 investor call on Monday, May 17, 2021 at 8:00 AM EDT to discuss financial results and provide a corporate update (Press release, Pieris Pharmaceuticals, MAY 10, 2021, View Source [SID1234579596]).

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To access the call, participants may dial 877-407-8920 (Toll Free US & Canada) or 412-902-1010 (International) at least five minutes prior to the start of the call. Alternatively, a listen-only audio webcast of the call can be accessed here.

For those unable to participate in the conference call or listen to the webcast, a replay will be available on the Investors section of the Company’s website, www.pieris.com.

On May 10, 2021 Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, reported its financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Intra-Cellular Therapies, MAY 10, 2021, View Source [SID1234579594]).

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"The acceptance of our sNDAs by the FDA is an important step towards a potential new treatment option for patients living with bipolar depression, a condition with a limited number of approved treatments. While preparing for this significant opportunity, our team will continue to execute on our commercial objectives for CAPLYTA and advance our robust pipeline," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.

First Quarter Financial Highlights:

Total revenues were $15.9 million for the first quarter of 2021, compared to $1.1 million of total revenues for the first quarter of 2020. Net product revenues of CAPLYTA were $15.6 million for the first quarter of 2021, compared to $0.9 million in net product revenues of CAPLYTA for the same period in 2020.
Cost of product sales were $1.5 million in the first quarter of 2021 compared to $0.1 million for the first quarter of 2020.
Research and development (R&D) expenses for the first quarter of 2021 were $15.1 million, compared to $16.0 million for the first quarter of 2020. This decrease is due primarily to a decrease in manufacturing expense and is partially offset by an increase of lumateperone clinical and non-clinical expenses.
Selling, general and administrative (SG&A) expenses were $52.6 million for the first quarter of 2021, compared to $34.1 million for the same period in 2020. This increase is primarily due to an increase in sales related labor costs and commercialization costs.
Net loss for the quarter ended March 31, 2021 was $52.7 million compared to a net loss of $47.4 million for the quarter ended March 31, 2020.
Cash, cash equivalents, restricted cash and investment securities totaled $613.4 million at March 31, 2021, compared to $658.8 million at December 31, 2020.
COMMERCIAL HIGHLIGHTS

Despite the continued impact of COVID-19 on the healthcare system during the first quarter, our commercial organization continued to effectively engage with our prescribing audience through a hybrid model of in-person and virtual interactions, enhanced by digital marketing initiatives.
First quarter CAPLYTA results reflect strong commercial execution delivering continued prescription growth, increasing total prescriptions 23% versus the fourth quarter.
CAPLYTA market access coverage is strong with greater than 95% of covered lives in both Medicare Part D and State Medicaid, the major payer channels in schizophrenia. Our LytaLink program continues to be highly competitive and effective in supporting prescribing physicians and eligible patients’ access to CAPLYTA.
CLINICAL HIGHLIGHTS

Lumateperone – Bipolar Depression Program:

The U.S. Food and Drug Administration (FDA) has accepted for review the sNDAs for lumateperone for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. The FDA has assigned a PDUFA target action date of December 17, 2021 for these applications.
At the American Psychiatric Association (APA) Annual Meeting held from May 1-3, 2021, we had several presentations describing lumateperone study results. These included results from Study ‘402, a global Phase 3 clinical trial evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with bipolar I or bipolar II disorder and analyses from Study ‘404 highlighting the efficacy results of patients with bipolar depression who exhibit mixed features. Another presentation summarized the overall safety and tolerability profile of the bipolar depression monotherapy program.
Other Lumateperone Programs

Mixed Features program: Study ‘403 evaluating lumateperone 42 mg in patients with major depressive disorder (MDD) and in patients with bipolar depression who exhibit mixed features is ongoing.
Adjunctive MDD program: Clinical conduct in two studies, Studies ‘501 and ‘502, our Phase 3 clinical trials evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD is anticipated to begin later this year.
Lumateperone Long Acting Injectable (LLAI) formulation: Study ITI-007-025, a Phase 1 single ascending dose study of LLAI, a formulation designed to be administered subcutaneously and to maintain therapeutic levels of lumateperone for at least one month is ongoing. Initial results from this study are anticipated in the second half of 2021.
CAPLYTA- Schizophrenia

Announced the publication of "Safety and tolerability of lumateperone 42 mg: An open-label antipsychotic switch study in outpatients with stable schizophrenia" (Correll et al. 2021) in the journal, Schizophrenia Research.
At APA we presented analyses from Study 303, our long-term safety schizophrenia study, evaluating the antidepressant effects of CAPLYTA in patients with schizophrenia with co-morbid depression, with and without concomitant antidepressant treatments.
Other Programs

ITI-1284 program: We introduced ITI-1284 ODT-SL, a deuterated form of lumateperone, a new molecular entity formulated as an orally disintegrating tablet for sublingual administration. We plan to initiate studies evaluating ITI-1284 ODT-SL for the treatment of behavioral disturbances in patients with dementia, the treatment of dementia-related psychosis and the treatment of certain depressive disorders in the elderly.
Phosphodiesterase type I inhibitor (PDE1) program: Our PDE1 inhibitor program is focused on diseases in which the PDE1 enzyme is over-expressed and/or abnormal immune cell function contributes to disease pathology. This suggests therapeutic potential across a variety of diseases, including neurological and cardiovascular diseases, as well as cancer.
We plan to advance our lead molecule, lenrispodun (ITI-214), into a Phase 2 clinical study in Parkinson’s disease in the second half of 2021.
At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, we presented preclinical data supporting the potential of PDE1 inhibition to enhance the anti-tumor effects of immunotherapies by altering the tumor micro-environment. Our prior studies elucidating the neuroprotective and anti-inflammatory effects of PDE1 inhibitors in the brain by regulating microglia function (brain resident macrophage-like cells) led to our exploration of similar effects outside the brain. Therefore, we hypothesized PDE1 inhibition could result in antitumor effects by controlling similar functions of macrophages in the tumor micro-environment. Our experiments indicate PDE1 inhibition prevents the migration and accumulation of monocytes and macrophages in the tumor micro-environment and could represent a novel and broadly applicable approach to the treatment of immune responsive cancers.

ITI-333 program in opioid use disorder: Study ITI-333-001, a Phase 1 single ascending dose study evaluating the safety, tolerability and pharmacokinetics of ITI-333 in healthy volunteers is ongoing. Results from this study are anticipated in the second half of 2021.
Conference Call and Webcast Details

The Company will host a live conference call and webcast today at 8:30 AM Eastern Time to discuss the Company’s financial results and provide a corporate update. The live webcast and subsequent replay may be accessed by visiting the Company’s website at www.intracellulartherapies.com. Please connect to the Company’s website at least 5-10 minutes prior to the live webcast to ensure adequate time for any necessary software download. Alternatively, please call 1-(844) 835-6563 (U.S.) or 1-(970) 315-3916 (international) to listen to the live conference call. The conference ID number for the live call is 3244409. Please dial in approximately 10 minutes prior to the call.

CAPLYTA (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.

Important Safety Information

Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

Warnings & Precautions: Antipsychotic drugs have been reported to cause:

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.
Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.

Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.

Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

Please click here to see full Prescribing Information including Boxed Warning.

About CAPLYTA (lumateperone)

CAPLYTA 42mg/day is an oral, once daily atypical antipsychotic approved for the treatment of schizophrenia of adults. While the mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

Lumateperone is being investigated for the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders. CAPLYTA is not FDA approved for these disorders.

On May 10, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the first quarter ending March 31, 2021 and recent company developments, along with a business outlook for 2021 (Press release, TG Therapeutics, MAY 10, 2021, View Source [SID1234579593]).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "2021 has been an incredibly impactful year, kicking off with our first approval coming ahead of schedule for UKONIQ to treat both relapsed or refractory Marginal Zone Lymphoma and Follicular Lymphoma. That was followed by the completion of a BLA submission for ublituximab in combination with UKONIQ (U2) to treat patients with CLL, and the full presentation of positive results from the ULTIMATE I & II Phase 3 trials in relapsing forms of MS. As a fully integrated commercial organization we are pleased with our progress thus far with the UKONIQ launch and we look forward to continuing to build our commercial infrastructure to support the potential approval and commercialization of U2 in CLL and ublituximab in RMS."

2021 Highlights & Recent Developments

UKONIQTM (umbralisib) in Relapsed or Refractory Marginal Zone Lymphoma & Follicular Lymphoma

Received accelerated approval from the U.S. Food and Drug Administration (FDA) on February 5, 2021 for UKONIQ to treat adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.
Launch efforts underway across the U.S. UKONIQ has payor coverage for 85-90% of Medicare and commercial lives and is included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for MZL and FL, consistent with the FDA-approved indications.
Published results from the UKONIQ monotherapy cohorts of the UNITY-NHL Phase 2b trial in patients with relapsed or refractory indolent non-Hodgkin Lymphoma (NHL) in the Journal of Clinical Oncology.
Ublituximab plus UKONIQ (U2) in Chronic Lymphocytic Leukemia

Completed a rolling submission of a Biologics License Application (BLA) to the FDA requesting approval of U2, as a treatment for patients with chronic lymphocytic leukemia (CLL), including both previously untreated and relapsed/refractory patients, based on the positive results from the UNITY-CLL Phase 3 trial.
Completed enrollment in the ULTRA-V Phase 2 trial, and launched the ULTRA-V Phase 3 randomized trial evaluating the triple combination of U2 plus venetoclax in patients with treatment naïve and relapsed or refractory CLL.
Ublituximab in Multiple Sclerosis

Presented positive results from the ULTIMATE I & II Phase 3 trials at the American Academy of Neurology 2021 Annual Meeting. Both trials met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period compared to teriflunomide in patients with relapsing forms of multiple sclerosis (RMS).
TG-1701 in B-cell Malignancies

Updated data from TG-1701, our BTK inhibitor, as a monotherapy and in combination with U2 in patients with B-cell malignancies has been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting being held in June 2021.
Remaining Key Objectives for 2021

Focus on the commercialization of UKONIQ in relapsed/refractory MZL and FL and expand commercialization capabilities in preparation for a potential launch of U2 for CLL and ublituximab in MS
Submit a BLA for ublituximab for the treatment of patients with RMS in Q3 2021, based on positive results from the ULTIMATE I & II Phase 3 trials
Receive notification from the FDA that the BLA for U2 in CLL has been accepted for filing and work closely with the Agency on its review of the application
Enroll into the newly launched ULTRA-V Phase 3 trial evaluating the triple combination of U2 plus venetoclax
Continue to advance our early pipeline candidates including TG-1501 (cosibelimab), TG-1701 and TG-1801
Financial Results for the Three Months Ended March 31, 2021

Product Revenue, net: Product revenue, net was approximately $0.8 million for the three months ended March 31, 2021, compared to zero during the comparable period in 2020. Net product revenues represent U.S. sales from our sole commercial product, UKONIQ, which received accelerated approval from the FDA on February 5, 2021, with launch later in the month.

R&D Expenses: Total research and development (R&D) expense was $63.1 million for the three months ended March 31, 2021, compared to $36.0 million for the three months ended March 31, 2020. The increase was due primarily to licensing milestone fees of approximately $14.0 million incurred during the first quarter of 2021 and an increase of approximately $5.5 million in non-cash compensation R&D expenses over the comparable quarter in 2020.

SG&A Expenses: Total selling, general and administrative (SG&A) expense was $26.8 million for the three months ended March 31, 2021 and $14.3 million for the three months ended March 31, 2020. The increase was due primarily to increased personnel and other selling, general and administrative costs associated with preparations for, and now execution of, the commercial launch of UKONIQ. We expect our selling, general and administrative expenses to increase for the remainder of 2021 in preparation for the potential launch of ublituximab as part of the U2 combination for CLL and as a monotherapy in MS.

Net Loss: Net loss was $90.6 million for the three months ended March 31, 2021 compared to $51.1 million for the three months ended March 31, 2020. Excluding non-cash compensation, the net loss for the three months ended March 31, 2021 was approximately $74.0 million, compared to a net loss of $40.0 million for the three months ended March 31, 2020.

Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $523.8 million as of March 31, 2021, which the Company believes will be sufficient to fund the Company’s planned operations into 2023.
CONFERENCE CALL INFORMATION
The Company will host a conference call today, May 10, 2021, at 8:30 AM ET, to discuss the Company’s first quarter ended March 31, 2021 financial results and provide a business outlook for the remainder of 2021.

To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for a period of 30 days after the call.